EP2515979B1 - Automatic identification of a patient interface device in a pressure support system - Google Patents

Automatic identification of a patient interface device in a pressure support system Download PDF

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Publication number
EP2515979B1
EP2515979B1 EP10800998.6A EP10800998A EP2515979B1 EP 2515979 B1 EP2515979 B1 EP 2515979B1 EP 10800998 A EP10800998 A EP 10800998A EP 2515979 B1 EP2515979 B1 EP 2515979B1
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Prior art keywords
pressure
flow
support system
patient
pressure support
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German (de)
English (en)
French (fr)
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EP2515979A1 (en
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Peter Chi Fai Ho
Zachary Dean Paul
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Koninklijke Philips NV
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Koninklijke Philips NV
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • A61M2205/702—General characteristics of the apparatus with testing or calibration facilities automatically during use

Definitions

  • the present invention pertains to apparatus employed in the delivery of a flow of breathing gas to the airway of a patient, and, more particularly, to pressure support system that automatically identifies a patient interface device that is coupled to a pressure generating system.
  • Non-invasive ventilation and pressure support therapies involve the placement of a respiratory patient interface device, including a mask component, on the face of a patient.
  • the mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth, or full face mask that covers the patient's face.
  • the patient interface device interfaces the ventilator or pressure support device with the airway of the patient so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient.
  • pressure support devices It is common for users of pressure support devices to have several different patient interface devices (e.g., different masks and different patient interface components), tubing options, exhaust assemblies, or other component options (such as bacteria filters) that they use for reasons such as comfort. It is important for the pressure support device to know which type of patient interface device or other component is being used so that it will know certain information about the components, such as, without limitation, mask resistance, mask compliance, mask leak rates. Based on this information, the pressure support device can adjust the operating parameters of the unit. In addition, certain comfort features or device functions can be enabled on the basis of a particular mask or peripheral being attached.
  • Non-invasive ventilation and pressure support therapies are often based on a software driven mode that determines a breath-per-breath characteristic, such as, for example, the delivered or output pressure.
  • the patient interface device being used often provides a specific exhaust flow pattern or characteristic, which is part of the computation of the output pressure. An effective and quick detection of the patient interface device in use and, hence, the exhaust flow characteristic can improve the accuracy of the output pressure computation.
  • a patient interface device typically includes three different types of leaks: total, intentional, and unintentional.
  • the total leak is the sum of the intentional leak and the unintentional leak.
  • the intentional leak is designed into the patient interface device (e.g., without limitation the exhaust assembly provided in the mask and/or patient circuit), in order that the patient does not re-breathe their own CO 2 .
  • the unintentional leak is, for example, an annoying leak that hits the patient in the eyes. Hence, it is desired to minimize the unintentional leak. However, it is believed that unlike the total leak, the unintentional leak cannot be measured.
  • the ventilator uses the corresponding intentional leak value (not shown) to subtract from the measured total leak in the calculation of the unintentional leak.
  • the ventilator uses the corresponding intentional leak value (not shown) to subtract from the measured total leak in the calculation of the unintentional leak.
  • Known systems are disclosed in WO2008/091164 , WO2006/092001 , US2007/277824 and WO03/000015 .
  • a pressure support system comprises a pressure generator, a pressure sensor, a flow sensor, and a controller cooperating with the pressure sensor and the flow sensor to control operation of the pressure generator.
  • the controller is structured to automatically identify a patient interface device in use with the pressure support system by detecting a change of exhaust flow of up to a predetermined amount across a predetermined pressure gradient of a pressure range of the pressure support system.
  • a method of automatically identifying a patient interface device in use with a pressure support system comprises: inputting a plurality of flow rates from a flow sensor; inputting a plurality of corresponding pressure points from a pressure sensor; employing the flow rates and the pressure points to detect a change of exhaust flow of up to a predetermined amount across a predetermined pressure gradient of a pressure range of the pressure support system; and comparing one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device in use.
  • the disclosed apparatus can detect the patient interface device in use automatically during a pressure support ventilating therapy based, for example, on either nil or minimal intentional exhaust flow variation across a particular pressure gradient. For example and without limitation, this can identify the patient interface device in use by detecting a nil or minimal exhaust flow variation or change (e.g., without limitation, about 1% to about 25% change) across a significant pressure gradient (e.g., without limitation, 5%, such as 1 cmH 2 0 for a common CPAP machine with a 20 cmH 2 O pressure output range; 25% of the pressure range of a pressure support system; about 50%, such as greater than 10 cmH 2 0 for a common CPAP machine with a 20 cmH 2 O pressure output range; about 100%).
  • a nil or minimal exhaust flow variation or change e.g., without limitation, about 1% to about 25% change
  • a significant pressure gradient e.g., without limitation, 5%, such as 1 cmH 2 0 for a common CPAP machine with a 20
  • the word "unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body.
  • the statement that two or more parts or components "engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.
  • the term “number” shall mean one or an integer greater than one (i.e., a plurality).
  • the term "patient” means a human being or other members of the animal kingdom.
  • the term “patient interface device” means a respiratory interface device, or a mask.
  • the term “mask” means a patient interface or a patient interface mask providing or delivering air or gas flow to a patient, such as for example and without limitation, a face mask, a nasal mask, an oral mask, a nasal/oral mask, a nasal pillow, a total face mark, any other device or apparatus that provides or delivers a suitable air or gas flow communicating function to a patient; or a mask employed in treating sleep disorders of a patient.
  • CPAP continuous positive airway pressure
  • COPD chronic Obstructive Pulmonary Disease - a lung disease (e.g., without limitation, chronic bronchitis; emphysema).
  • pressure support system 50 includes gas flow generator 52, such as a blower used in a conventional continuous positive airway pressure (CPAP) or bi-level pressure support system, which receives breathing gas, generally indicated by arrow C, from any suitable source, e.g., a pressurized tank of oxygen or air, the ambient atmosphere, or a combination thereof.
  • Gas flow generator 52 generates a flow of breathing gas, such as air, oxygen, or a mixture thereof, for delivery to an airway (not shown) of patient 54 at relatively higher and lower pressures, i.e., generally equal to or above ambient atmospheric pressure.
  • Gas flow generator 52 is capable of providing a flow of breathing gas ranging in pressure from, for example and without limitation, about 3 cmH 2 O to about 30 cmH 2 O.
  • the pressurized flow of breathing gas is delivered via delivery conduit 56 to patient interface device 58, which is typically worn by or otherwise attached to patient 54 to communicate the flow of breathing gas to the airway of patient 54.
  • Delivery conduit 56 and patient interface device 58 are typically collectively referred to as a patient circuit.
  • Pressure support system 50 is what is known as a single-limb system, meaning that patient circuit includes only delivery conduit 56 connecting patient 54 to pressure support system 50.
  • exhaust vent 57 is provided in delivery conduit 56 for venting exhaled gasses from the system as indicated by arrow E.
  • Exhaust vent 57 can be provided at other locations in addition to or instead of in delivery conduit 56, such as in patient interface device 58.
  • Exhaust vent 57 can have a wide variety of configurations depending on the desired manner in which gas is to be vented from pressure support system 50.
  • Pressure support system 50 can be a two-limb system, having a delivery conduit and an exhaust conduit connected to patient 54.
  • the exhaust conduit carries exhaust gas from patient 54 and includes an exhaust valve at the end distal from patient 54.
  • the exhaust valve is typically actively controlled to maintain a desired level or pressure in the system, which is commonly known as positive end expiratory pressure (PEEP).
  • PEEP positive end expiratory pressure
  • pressure support system 50 includes a pressure controller in the form of valve 60 provided in delivery conduit 56.
  • Valve 60 controls the pressure of the flow of breathing gas from flow generator 52 delivered to patient 54.
  • Flow generator 52 and valve 60 are collectively referred to a pressure generator because they act in concert to control the pressure and/or flow of gas delivered to patient 54.
  • other techniques for controlling the pressure of the gas delivered to patient 54 such as varying the blower speed of flow generator 52, either alone or in combination with a pressure control valve, can be employed.
  • valve 60 is optional depending on the technique used to control the pressure of the flow of breathing gas delivered to patient 54. If valve 60 is eliminated, the pressure generator corresponds to flow generator 52 alone, and the pressure of gas in patient circuit is controlled, for example, by controlling the motor speed of flow generator 52.
  • Pressure support system 50 further includes flow sensor 62 that measures the flow of the breathing gas within delivery conduit 56.
  • Flow sensor 62 is interposed in line with delivery conduit 56, most preferably downstream of valve 60.
  • Flow sensor 62 generates a flow signal that is provided to controller 64 and is used by controller 64 to determine the flow of gas at patient 54.
  • controller 64 uses controller 64 to determine the flow of gas at patient 54.
  • other techniques for measuring the respiratory flow of patient 54 can be employed, such as measuring the flow directly at patient 54 or at other locations along delivery conduit 56 and communicating the measured flow by direct electrical connection between a flow sensor (not shown) and controller 64, measuring patient flow based on the operation of flow generator 52, and measuring patient flow using a flow sensor (not shown) upstream of valve 60.
  • Pressure support system 50 also includes pressure sensor 68 operatively coupled to controller 64 that detects the pressure of the gas at patient 54.
  • Pressure sensor 68 is in fluid communication with patient interface device 58 via delivery conduit 56.
  • the pressure at patient 54 is estimated based on the known pressure drop that occurs in delivery conduit 56.
  • the patient pressure can be measured directly at patient interface device 58 using a pressure sensor (not shown) incorporated therein and communicating the measured pressure by direct electrical connection (not shown) between such pressure sensor (not shown) and controller 64.
  • Controller 64 may be, for example, a microprocessor, a microcontroller or some other suitable processor or processing device, that includes or is operatively coupled to a memory (not shown) that provides a storage medium for data and software executable by controller 64 for controlling the operation of pressure support system 50.
  • a user interface such as input/output device 66, is provided for setting various parameters used by pressure support system 50, as well as for displaying and outputting information and data to a user, such as a clinician or caregiver or patient 54.
  • Pressure support system 50 can essentially function as a CPAP pressure support system, and, therefore, can include all of the capabilities necessary in such systems in order to provide appropriate CPAP pressure levels to patient 54. This includes receiving the necessary parameters, via input commands, signals, instructions or other information, for providing appropriate CPAP pressure, such as maximum and minimum CPAP pressure settings.
  • Other pressure support methodologies include but are not limited to, BiPAP AutoSV, AVAPS, Auto CPAP, and BiPAP Auto.
  • controller 64 estimates the leakage of gas from pressure support system 50 using any conventional technique and incorporates this leak estimation into the determination of the actual patient flow.
  • This leak estimation is required in a single-limb system, because a single-limb system includes a known leak through exhaust vent 57 as well as other unknown leaks, such as leaks at the patient contact site of the patient interface device 58 and at various conduit couplings on patient circuit.
  • leak estimation may not be required, because a flow sensor is typically provided at the exhaust vent to measure, directly, the flow of exhaust gas. In such a system, the patient flow can be determined by subtracting the measured exhaust flow from the measured flow delivered to the patient. It can be appreciated that leak detection can be performed in a two-limb system to increase the accuracy of the patient flow determination.
  • FIG. 3 shows a routine 100 executed by processor 101 of controller 64 of FIG. 2 .
  • the mask auto detection is enabled. This can be, for example and without limitation, a configuration parameter of controller 64. If so, then at step 104, patient 54 is instructed (e.g., through input/output device 66) to place, for example, patient interface device 58 (e.g., a particular type of mask unknown to controller 64) on their face. Providing a specific instruction to the patient is optional if the system detects that the user already has placed the patient interface in communication with his or her airway.
  • patient interface device 58 e.g., a particular type of mask unknown to controller 64
  • controller 64 functions to deliver specific pressure levels to patient 54 by controlling gas flow generator 52 and/or valve 60. Then, at 108, controller 64 measures, for example, two patient flows at two corresponding pressure levels from flow sensor 62 and pressure sensor 68, respectively.
  • step 110 it is determined if the delta flow (i.e., the difference between the two patient flows) of step 108 is less than a predetermined value, k.
  • routine 100 can identify a change of flow rate employing flow sensor 62, the change of flow rate being the difference between two different flow readings from flow sensor 62 taken at two different corresponding pressure points from pressure sensor 68. If the test passes at step110, then at step 112, the measured flow at one pressure level is compared to, for example and without limitation, lookup table values to determine mask type as will be explained.
  • controller 64 causes delivery of customized flow and pressure to patient 54 based upon the mask type. For example, controller 64 can control the pressure generator to provide pressure and flow to the mask based upon the type of mask.
  • patient 54 may be instructed (e.g., through input/output device 66) to manually input the mask type (e.g., as displayed on or with patient interface device 58) using input/output device 66.
  • step 114 is executed as was discussed, above.
  • the example routine 100 provides a method of automatically identifying patient interface device 58 in use with pressure support system 50. This inputs a plurality of flow rates from flow sensor 62, inputs a plurality of corresponding pressure points from pressure sensor 68, employs the flow rates and the pressure points to detect a change of exhaust flow change of up to a predetermined amount across a predetermined pressure gradient of a pressure range of pressure support system 50, and compares one of the flow rates and one of the corresponding pressure points to a plurality of predetermined flow rates and a number of predetermined pressure points to determine a type of mask as the patient interface device 58 in use.
  • controller 64 requests manual input from input/output device 66 of the type of mask in use.
  • routine 100 is normally executed at startup, it will be appreciated that controller 64 can execute the same routine 100 or a similar routine (e.g., including steps 106, 108, 110 and 112) at other times to identify patient interface device 58, which is in use.
  • routine 100 is normally executed at startup, it will be appreciated that controller 64 can execute the same routine 100 or a similar routine (e.g., including steps 106, 108, 110 and 112) at other times to identify patient interface device 58, which is in use.
  • routine 100 can employ a flow rate from flow sensor 62 and a corresponding pressure point from pressure sensor 68, and compare that flow rate and corresponding pressure point to a plurality of predetermined flow rates and a number of predetermined pressure points (e.g., without limitation, in a lookup table 118 in memory (not shown) of controller 64 to determine the mask type).
  • the mask type corresponds to curve 2 (e.g., without limitation, lookup table 118 can define six different mask types to curves 2, 3, 4, 5, 6, 7, respectively).
  • Step 114 of FIG. 3 controls the pressure generator to provide pressure and flow to patient interface device 58 based upon the type of mask.
  • Routine 100 and flow sensor 62 detect a constant or nearly constant flow with a flow variation tolerance (e.g., without limitation, as low as about 1 SLPM; as high as about 5 SLPM) depending on the given pressure gradient.
  • routine 100 computes, at 114, the output flow and pressure based on a specific relatively constant flow curve corresponding to the specific patient interface device 58 in use employing PEVTM technology. See, for example, International Patent Application Pub. No. WO/2009/136333 and U.S. Provisional Patent Application No. 61/051,093, filed May 7, 2008 . This can be further explained with reference to exhaust flow curves of FIG. 1 .
  • Curve 1 is a conventional exhaust flow curve employed by a typical patient interface device without PEVTM technology.
  • Curves 2 to 7 are various exhaust flow curves employed by a patient interface device, such as 58, with PEVTM technology. Each patient interface device with PEVTM technology can provide its own “constant” or nearly constant flow rate depending on the desired therapy.
  • curve 2 is an ideal flow curve for treating COPD patients with a flat 30 SLPM exhaust rate (detecting the exhaust flow change of about 0% and responsively determining a predetermined type of mask as patient interface device 58 in use)
  • curves 3-7 are flow curves for treating sleep apnea patients which prefer to have a non constant flow exhaust rate proportional to pressure in the low pressure range in order to preserve moisture.
  • the constant pressure segment is onset from a specific pressure point. For example, curve 7 has the onset point at about 3 cmH 2 O, while curve 5 has the onset point delayed to about 5 cmH 2 O.
  • Step 110 of routine 100 looks for the lack of significant change in exhaust flow over one pressure gradient or multiple pressure gradients in order to determine the mask type.
  • routine 100 uses the specific mask type and corresponding stored pressure-flow data.
  • each component in the circuit from gas flow generator 52 to patient 54, including patient interface device 58, has its own resistance, which can be considered as being a leak instead of a resistance.
  • Each component has a relatively very small unintentional leak and a relatively higher intentional leak in order to purge CO 2 (from exhalation).
  • Each leak can now be understood as being a flow resistance.
  • Each of the component flow resistances affects the pressure as a pressure drop.
  • the therapy is to deliver pressure to patient 54.
  • the various component pressure drops reduce the pressure that reaches patient 54. Hence, flow needs to be increased in order to make up the difference. Pressure is generated from flow by gas flow generator 52 and/or valve 60.
  • routine 100 looks for a change of flow rate as measured, for example, by flow sensor 62.
  • This change of flow rate is the difference between two different flow readings taken at two different pressure points at 108 ( FIG. 3 ).
  • curve 1 of FIG. 1 which is for a conventional patient interface device with variable exhaust flow from a fixed opening, at 7.5 cmH 2 O the flow is about 22 SLPM, and at 15 cmH 2 O the flow is about 32 SLPM.
  • a detecting range of the operating pressure of pressure support system 50 is preferably employed.
  • the pressure gradient is 7.5 cmH 2 O (i.e., P2 P1) for an operating pressure up to 30 cmH 2 O (i.e., 25% of 30 cmH 2 O is 7.5 cmH 2 O in this example).
  • the 25% pressure gradient is 5 cmH 2 O.
  • routine 100 can operate, for example and without limitation, with such changes from 0% to about 25% or larger.
  • One example range of the nil or minimal change in exhaust flow or intentional leak is from about 1% to about 5.4% depending on the pressure gradient (for example, for a relatively larger gradient there is a relatively higher percentage change, and for a relatively smaller gradient there is a relatively smaller percentage change).
  • an ideal range of exhaust flow change of 0% could be achieved with relatively tighter tolerances, it might be impractical to achieve.
  • the routine 100 can operate with non-limiting example pressure gradients of about 5% of the maximum pressure of pressure support system 50 (e.g., 1 cmH 2 0 for a common CPAP machine with a 20 cmH 2 O pressure output range), about 25% of the maximum pressure of pressure support system 50, or about 50% of the maximum pressure of pressure support system 50 (e.g., greater than 10 cmH 2 0 for a common CPAP machine with a 20 cmH 2 O pressure output range).
  • the exhaust flow change can be proportional to the pressure range and depend upon the actual performance of the patient interface device.
  • Non-limiting examples include flow changes of 5%, 10% and 25% for predetermined pressure gradients of 5%, 50% and 100%, respectively.
  • routine 100 of FIG. 3 need not make variable compensation at different pressures due to changes in the purging flow rate.
  • routine 100 detects, for example and without limitation, a nil or minimal change in exhaust flow across a predetermined pressure gradient, it can make a suitable minimal adjustment to compensate for a fixed or approximately fixed flow rate across the entire operating pressure range.
  • an ideal "constant" flow curve, or plateau curve, like curve 2 provides a constant leak rate across a relatively wide range of pressure, which is above a predetermined pressure (e.g., without limitation, about 1.2 cmH 2 O).
  • Other curves, like curves 3-7, can make the flow respond more proportionally with the pressure at a relatively lower pressure range in order to reserve moisture, while allowing a near constant flow kick in at a designated pressure, such as for example, about 5 cmH 2 O in most of these curves.
  • curves 3-7 provide a first flow that is proportional with pressure below a predetermined pressure and a second flow that is about constant above the predetermined pressure. This delay in the constant flow portion is designed mainly for CPAP or BiPAP users to treat sleep apnea.
  • effective CO 2 removal is vital to the therapy such that a relatively plateau effect is desired.
  • the disclosed apparatus preferably employ PEVTM (Plateau Exhalation Valve) technology and look for a nil or minimal change in exhaust flow across a significant pressure gradient to determine the specific patient interface device 58 (e.g., mask) in use.
  • patient interface device 58 can include an external or built-in exhalation device employing PEVTM technology.
  • patient interface devices such as 58, employing PEVTM technology
  • the disclosed apparatus can function with conventional technology that does not employ PEVTM technology, although it may not apply to a conventional mask with a fixed opening exhaust. There, for example, for a fixed orifice, the flow change will exceed 50%.
  • Example applications for the disclosed apparatus include patient interface devices; and pressure support ventilating therapy or noninvasive positive airway pressure therapy, such as CPAP and Bi-Level, which employs an exhaust valve to purge CO 2 .
  • pressure support ventilating therapy or noninvasive positive airway pressure therapy such as CPAP and Bi-Level, which employs an exhaust valve to purge CO 2 .
  • the disclosed apparatus allows a potentially infinite expansion of the type of patient interface device 58 in use to be detected with a significant difference in exhaust flow characteristics in response to therapy needs without updating routine 100 ( FIG. 3 ), since it looks, for example and without limitation, for a nil or minimal change in exhaust flow rate.
  • steps 106,108,110,112 can readily distinguish between curve 1 and curves 2-7 of FIG. 1 .
  • the mask type for curve 1 is manually entered at 116, while the mask types for curves 2-7 are advantageously automatically determined at 112.
  • routine 100 can either match the new device to one of the existing curves 2-7, or can add another curve to lookup table 118 by inputting, for example, its pressure-flow characteristic at a corresponding pressure point to lookup table 118.
  • This is in complete contrast to known ventilators that solely rely on stored data in a fixed, predetermined database to look for a match. That approach has the disadvantage of limiting the number of patient interface devices to detect without upgrading such fixed, predetermined database.

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EP10800998.6A 2009-12-21 2010-11-16 Automatic identification of a patient interface device in a pressure support system Active EP2515979B1 (en)

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US28845709P 2009-12-21 2009-12-21
PCT/IB2010/055203 WO2011077274A1 (en) 2009-12-21 2010-11-16 Automatic identification of a patient interface device in a pressure support system

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CN (1) CN102665809B (zh)
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BR (1) BR112012015035A2 (zh)
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AU2010334488B2 (en) 2014-07-10
RU2567461C2 (ru) 2015-11-10
US9199048B2 (en) 2015-12-01
RU2012131413A (ru) 2014-01-27
JP2013514821A (ja) 2013-05-02
CN102665809A (zh) 2012-09-12
AU2010334488A1 (en) 2012-08-09
CN102665809B (zh) 2016-01-06
US20120247470A1 (en) 2012-10-04
EP2515979A1 (en) 2012-10-31
WO2011077274A1 (en) 2011-06-30
BR112012015035A2 (pt) 2017-06-27

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